FDA.reportPublic FDA data

MediChoice Moisturizing Lip Balm SPF15

Product NDC
39892-0940
11-digit product format
398920940
Labeler code
39892
Product ID
39892-0940_40b41656-3e4a-5597-e063-6394a90a952a
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE
Dosage form
CREAM
Route
TOPICAL
Labeler
O&M HALYARD, INC.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-12-22
Substance
AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE
Active strength
30; 65; 50; 15 mg/g; mg/g; mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
MediChoice Moisturizing Lip Balm SPF15
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/g
OCTINOXATE65 mg/g
OCTISALATE50 mg/g
OCTOCRYLENE15 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
00327815-28f0-4198-bca7-c8ae768ff416Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
39892-0940-1MediChoice Moisturizing Lip Balm SPF154.2 g in 1 POUCHCREAM4.23
39892-0940-2MediChoice Moisturizing Lip Balm SPF15100 in 1 BOXCREAM1003
39892-0940-2MediChoice Moisturizing Lip Balm SPF154.2 g in 1 CASECREAM4.23
39892-0940-3MediChoice Moisturizing Lip Balm SPF154.2 g in 1 CASECREAM4.23
39892-0940-3MediChoice Moisturizing Lip Balm SPF15100 in 1 BOXCREAM1003

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 274 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fruit of the Earth Sun Town City Mineral SPF 70 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit Of The Earth, Inc.f540b0f6-3e6c-43a7-e053-2a95a90aba742024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City Mineral SPF 30 SunscreenTITANIUM DIOXIDE, ZINC OXIDEFruit Of The Earth, Inc.f4481bf3-6dc7-5641-e053-2a95a90ad9382024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town CityLIP BALM SPF 30 SUNSCREEN STICKFruit of the Earth, Inc.3ec16996-ae86-4f5b-b1fd-c7b509cc5d502024-10-18WarningsExact identifier
application number: M020
Cabana Beach Club with Mentha and Essential Oils SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.f452df0c-ea8d-e25c-e053-2995a90a11432024-10-18WarningsExact identifier
application number: M020
FRUIT OF THE EARTH 100 DRY TOUCH BROAD SPECTRUM SPF 100 FACE SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEFRUIT OF THE EARTH, INC.fa18f1a9-7a6a-856e-e053-6294a90aeafa2024-10-18WarningsExact identifier
application number: M020
Cabana Beach Club with Blood Orange and Essential Oils SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.f452f94a-d2f1-60ec-e053-2995a90a88272024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City Mineral SPF 50 SunscreenTITANIUM DIOXIDE, ZINC OXIDEFruit Of The Earth, Inc.f45d25d2-9305-5858-e053-2a95a90a7f7b2024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City Mineral SPF 70 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit Of The Earth, Inc.f53fff7a-ef8b-19c4-e053-2a95a90a4a2a2024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth LUV THAT SUN Sport Sunscreen Continuous SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEFruit Of The Earth, Inc.fd68012d-814b-ac07-e053-6394a90afc682024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth LUV THAT SUN Sport Sunscreen Ultra SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFRUIT OF THE EARTH, INC.fd687b34-e4c6-0458-e053-6394a90ac0642024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth LUV THAT SUN Kids Sunscreen Ultra SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFRUIT OF THE EARTH, INC.fd786a06-88b7-fa35-e053-6394a90a84a52024-10-18WarningsExact identifier
application number: M020
Chemical Sunscreen SPF50 with AntipollutionHOMOSALATE, OCTOCRYLENE, AVOBENZONE, OCTISALATE SUNSCREENSwiss-American CDMO, LLC59efb7dd-83f9-4222-9b7e-ea17ac4ece002024-10-18WarningsExact identifier
application number: M020
CVS Health SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS Pharmacyf0d6ac48-3d57-0f5c-e053-2a95a90a87cf2024-10-17WarningsExact identifier
application number: M020
CVS HEALTH SPORT SPF 50 CLEAR SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYf13f7361-56b3-7ea8-e053-2995a90a76412024-10-17WarningsExact identifier
application number: M020
CVS Health SPF 50 Ultra ProtectionAVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENECVS PHARMACYf11650bb-90a0-78a1-e053-2995a90a8e4c2024-10-17WarningsExact identifier
application number: M020
CVS Health Sport SPF 70 ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECVS Pharmacyf31dd448-dc79-21f1-e053-2a95a90a7bb62024-10-17WarningsExact identifier
application number: M020
CVS Health SPF 30 Breakout Free FaceAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYf41478c8-76c0-727f-e053-2a95a90a86692024-10-17WarningsExact identifier
application number: M020
CVS Health SPF 30 Ultra ProtectionAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYf12ba764-afea-3f81-e053-2a95a90a12912024-10-17WarningsExact identifier
application number: M020
CVS Health SPF 30 Ultra SheerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYf32ec4ef-352e-6a78-e053-2995a90af4912024-10-17WarningsExact identifier
application number: M020
CVS Health Sport SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYf40e5664-e3ca-badf-e053-2a95a90a913e2024-10-17WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
39892-0940-1398920940014.2 g in 1 POUCH (39892-0940-1) 4.2 g2014-12-22NoNoCurrent
39892-0940-239892094002100 CASE in 1 BOX (39892-0940-2) / 4.2 g in 1 CASE100 case2014-12-22NoNoCurrent
39892-0940-339892094003100 CASE in 1 BOX (39892-0940-3) / 4.2 g in 1 CASE100 case2014-12-22NoNoCurrent